US FDA grants fast track status for GSK’s HIV drug

BY OUR PHARMA CORRESPONDENT

23 July, 2005: The United States Food and Drug Administration has granted fast-track designation to GlaxoSmithKline's HIV protease inhibitor (PI) 640385 (VX-385).
640385 is one of the leads resulted from GSK's collaboration with Vertex.

The research association between GlaxoSmithKline Vertex has generated three novel HIV protease inhibitor product candidates over the past 12 years, a GSK release said.

The fast track designation was based on positive phase IIa data from a clinical study of 640385 in HIV-infected patients, as well as results from in vitro studies indicating 640385’s antiviral activity against HIV-1 strains resistant to a number of currently marketed protease inhibitors.

Vertex expects that GSK will present preliminary phase IIa results at a medical conference in the second half of 2005.

Vertex Pharmaceuticals Incorporated co-promotes with GlaxoSmithKline the new HIV protease inhibitor, Lexiva, in the United States and Agenerase in Europe.

Vertex and Merck are collaborating on the discovery and development of Aurora kinase inhibitors, which hold the potential to play a major role for the treatment of a wide range of cancers. In North America, Vertex is currently developing drugs targeting hepatitis C.